Study of the Relationship Between Blood Vessels and Insulin Response in Adolescents

NCT ID: NCT00374361

Last Updated: 2016-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

66 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-07-31

Study Completion Date

2006-06-30

Brief Summary

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This study is designed to determine whether there is a relationship between the way insulin and blood vessels work. The difference in the interaction between Caucasian and African American adolescents will also be examined. This may play a role in the differing rates of heart disease and diabetes between the two groups.

Detailed Description

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Purpose: The purpose of the research is to learn more about how the lining of arteries in the body (called the endothelium) and insulin work in adolescents. Abnormalities in how the blood vessels and insulin work in adolescents may cause high blood pressure, type 2 diabetes, stroke and heart disease.

Healthy adolescents between 8 and 18 years of age are being studied in the Ohio State University General Clinical Research Center. Two visits will be necessary. One will be a screening visit to determine the child's stage of puberty and obtain a medical history. The second will be the study visit. During the latter, blood vessel function will be determined by studying the change in forearm blood flow before and after blood flow to the forearm is stopped. Insulin sensitivity will be determined using glucose water given into a vein.

Conditions

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Diabetes Mellitus, Type 2 Hypertension Heart Disease Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Caucasian Adolescents

Caucasian Adolescents

No interventions assigned to this group

African-American Adolescents

African-American Adolescents

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Caucasian or African American adolescent
* Between 8 and 18 years of age

Exclusion Criteria

* Pregnancy
* Chronic Disease
* Acute Disease
* Medication Requirement
Minimum Eligible Age

8 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nationwide Children's Hospital

OTHER

Sponsor Role collaborator

Ohio State University

OTHER

Sponsor Role lead

Responsible Party

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Robert Hoffman

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert P Hoffman, MD

Role: STUDY_CHAIR

Ohio State University

Locations

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Ohio State University

Columbus, Ohio, United States

Site Status

Countries

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United States

References

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Hoffman RP. Indices of insulin action calculated from fasting glucose and insulin reflect hepatic, not peripheral, insulin sensitivity in African-American and Caucasian adolescents. Pediatr Diabetes. 2008 Jun;9(3 Pt 2):57-61. doi: 10.1111/j.1399-5448.2007.00350.x. Epub 2008 Jan 21.

Reference Type RESULT
PMID: 18221434 (View on PubMed)

Duck MM, Hoffman RP. Impaired endothelial function in healthy African-American adolescents compared with Caucasians. J Pediatr. 2007 Apr;150(4):400-6. doi: 10.1016/j.jpeds.2006.12.034.

Reference Type RESULT
PMID: 17382119 (View on PubMed)

Hoffman RP. Increased fasting triglyceride levels are associated with hepatic insulin resistance in Caucasian but not African-American adolescents. Diabetes Care. 2006 Jun;29(6):1402-4. doi: 10.2337/dc06-2460. No abstract available.

Reference Type RESULT
PMID: 16732033 (View on PubMed)

Xie L, Hoffman RP, Veng-Pedersen P. Noncompartmental pharmacokinetics analysis of glucose-stimulated insulin response in African-American and Caucasian youths. Biopharm Drug Dispos. 2009 Apr;30(3):117-25. doi: 10.1002/bdd.652.

Reference Type RESULT
PMID: 19288584 (View on PubMed)

Other Identifiers

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AHA 0355195B

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

ENDO 203

Identifier Type: -

Identifier Source: org_study_id

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